Promethazine; Codeine Solution

What is this medication?

PROMETHAZINE; CODEINE (proe METH a zeen; KOE deen) treats the symptoms of the common cold, allergies, or flu. It works by reducing cough, a runny or stuffy nose, and red, itchy eyes. It is a combination of an antihistamine and an opioid cough suppressant.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Pentazine with Codeine

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Addison disease
• Brain tumor
• Diabetes
• Frequently drink alcohol
• Gallbladder disease
• Glaucoma
• Head injury
• Heart disease
• History of irregular heartbeat
• History of substance use disorder
• Kidney disease
• Liver disease
• Low blood pressure
• Lung or breathing disease, such as asthma
• Mental health condition
• Pancreatic disease
• Seizures
• Stomach or intestine problems
• Thyroid disease
• Trouble passing urine
• An unusual or allergic reaction to codeine, promethazine, phenothiazines, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medication by mouth. Follow the directions on the prescription label. You can take it with or without food. If it upsets your stomach, take it with food. Use a specially marked spoon or container to measure each dose. Ask your pharmacist if you do not have one. Household spoons are not accurate. Do not to overfill. Rinse the measuring device with water after each use. Take your medication at regular intervals. Do not take it more often than directed.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. This medication is not approved for use in children.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medication with any of the following:

• Alcohol
• Antihistamines for allergy, cough, and cold
• Certain medications for anxiety or sleep
• Certain medications for depression, such as amitriptyline, fluoxetine, sertraline
• Certain medications for seizures, such as carbamazepine, phenobarbital, phenytoin, primidone
• Cisapride
• Dofetilide
• Dronedarone
• General anesthetics, such as halothane, isoflurane, methoxyflurane, propofol
• Local anesthetics, such as lidocaine, pramoxine, tetracaine
• MAOIs, such as Carbex, Eldepryl, Marplan, Nardil, and Parnate
• Medications that relax muscles for surgery
• Metoclopramide
• Other opioid medications for pain or cough
• Phenothiazines, such as chlorpromazine, mesoridazine, prochlorperazine, thioridazine
• Pimozide
• Quinidine

This medication may also interact with the following:

• Antiviral medications for HIV or hepatitis
• Atropine
• Certain antibiotics, such as erythromycin, clarithromycin
• Certain medications for bladder problems, such as oxybutynin, tolterodine
• Certain medications for fungal infections, such as ketoconazole and itraconazole
• Certain medications for Parkinson disease, such as benztropine, trihexyphenidyl
• Certain medications for stomach problems, such as dicyclomine, hyoscyamine
• Certain medications for travel sickness, such as scopolamine
• Ipratropium
• Other medications that cause heart rhythm changes
• Rifampin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

You may develop tolerance to this medication if you take it for a long time. Tolerance means that you will get less symptom relief with time. Tell your care team if your symptoms do not start to get better or if they get worse.

Taking this medication with other substances that cause drowsiness, such as alcohol, benzodiazepines, or other opioids can cause serious side effects. Give your care team a list of all medications you use. They will tell you how much medication to take. Do not take more medication than directed. Call emergency services if you have problems breathing or staying awake.

Long term use of this medication may cause your brain and body to depend on it. This can happen even when used as directed by your care team. You and your care team will work together to determine how long you will need to take this medication. If your care team wants you to stop this medication, the dose will be slowly lowered over time to reduce the risk of side effects.

This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects.

This medication can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps, tanning beds, or tanning booths.

This medication will cause constipation. If you do not have a bowel movement for 3 days, call your care team.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy and drinking plenty of water may help. Contact your care team if the problem does not go away or is severe.

Talk to your care team if you may be pregnant. Prolonged use of this medication during pregnancy can cause temporary withdrawal in a newborn.

Talk to your care team before breastfeeding. Changes to your treatment plan may be needed. If you breastfeed while taking this medication, seek medical care right away if you notice the child has slow or noisy breathing, is unusually sleepy or not able to wake up, or is limp.

Long-term use of this medication may cause infertility. Talk to your care team if you are concerned about your fertility.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• CNS depression—slow or shallow breathing, shortness of breath, feeling faint, dizziness, confusion, trouble staying awake
• High fever, stiff muscles, increased sweating, fast or irregular heartbeat, and confusion, which may be signs of neuroleptic malignant syndrome
• Infection—fever, chills, cough, or sore throat
• Low adrenal gland function—nausea, vomiting, loss of appetite, unusual weakness or fatigue, dizziness
• Low blood pressure—dizziness, feeling faint or lightheaded, blurry vision
• Sudden eye pain or change in vision such as blurry vision, seeing halos around lights, vision loss
• Trouble passing urine
• Uncontrolled and repetitive body movements, muscle stiffness or spasms, tremors or shaking, loss of balance or coordination, restlessness, shuffling walk, which may be signs of extrapyramidal symptoms (EPS)

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Confusion
• Constipation
• Dizziness
• Drowsiness
• Dry mouth
• Headache
• Nausea
• Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep this medication out of reach of children and pets. Store it out of sight in a safe place. Do not share it with others. Misuse of this medication is dangerous and against the law.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Protect from light. Get rid of any unused medication after the expiration date.

This medication may cause harm and death if it is taken by other adults, children, or pets. It is important to get rid of the medication as soon as you no longer need it or it is expired. To get rid of this medication:

• Take the medication to a take-back program. Check with your pharmacy or law enforcement to find a location.
• Follow the steps given to you by your pharmacy. You may be given a pre-paid mail-back envelope or disposal product to safely get rid of your medication.
• If other options are not available, check the package insert or medication guide to see if it should be flushed down the toilet or put in your trash at home. If you are not sure, ask your care team. If it is safe to put it in your trash, empty the medication out of the container. Mix it with cat litter, dirt, used coffee grounds, or another unwanted substance. Seal the mixture in a container, such as a plastic bag. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.